医学
心力衰竭
心脏病学
内科学
危险系数
射血分数
心脏再同步化治疗
QRS波群
置信区间
植入式心律转复除颤器
随机对照试验
优势比
右束支阻滞
左束支阻滞
心电图
作者
Béla Merkely,Róbert Hatala,Jerzy Krzysztof Wranicz,Gabor Z. Duray,Csaba Földesi,Zoltán Som,M Németh,Kinga Gościńska-Bis,László Gellér,Endre Zima,István Osztheimer,Levente Molnár,Júlia Karády,Gerhard Hindricks,Ilan Goldenberg,Helmut U. Klein,Mátyás Szigeti,Scott D. Solomon,Valentina Kutyifa,Attila Kovács,Annamária Kosztin
标识
DOI:10.1093/eurheartj/ehad591
摘要
De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain.In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization.Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)].In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.
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